GW786034 in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060151
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : September 20, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

May 6, 2003
May 7, 2003
September 20, 2013
December 2002
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Safety and toxicity assessed weekly during treatment
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Complete list of historical versions of study NCT00060151 on Archive Site
Disease response every 9 weeks
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GW786034 in Treating Patients With Advanced Solid Tumors
A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors

RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in treating patients with advanced solid tumors.


  • Determine the safety and tolerability of GW786034 in patients with advanced solid tumors.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the clinical response in patients treated with this drug.
  • Evaluate the effect of this drug on biomarkers of angiogenesis activity in order to estimate activity and to determine the minimum biologically active dose in these patients.

OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.

Patients receive oral GW786034 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 2-6 patients receive escalating doses of GW786034 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 21 days.

PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.

Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pazopanib hydrochloride
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Hurwitz HI, Dowlati A, Saini S, Savage S, Suttle AB, Gibson DM, Hodge JP, Merkle EM, Pandite L. Phase I trial of pazopanib in patients with advanced cancer. Clin Cancer Res. 2009 Jun 15;15(12):4220-7. doi: 10.1158/1078-0432.CCR-08-2740. Epub 2009 Jun 9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2009
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  • Histologically confirmed advanced solid tumor
  • Refractory to standard therapy or for which no standard therapy exists
  • No untreated leptomeningeal or brain metastases

    • Previously treated brain metastases are allowed if currently asymptomatic and patient is off steroids and antiseizure medications for more than 3 months before study entry



  • 21 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 12 weeks


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if tumor involvement)


  • Creatinine clearance at least 60 mL/min


  • No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg on 2 consecutive measurements separated by 1 week)
  • No arterial or venous thrombosis (including cerebrovascular accident) within the past 3 months
  • No myocardial infarction within the past 3 months
  • No unstable angina within the past 3 months
  • No cardiac angiopathy or stenting within the past 3 months
  • No cardiac pacemaker


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 21 days after study treatment
  • Able to swallow and retain oral medication
  • Good venous access
  • No prior or concurrent gastrointestinal disease
  • No prior or concurrent condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug
  • No other unstable, pre-existing major medical condition
  • No orthopedic pins or rods or other embedded metal that would preclude undergoing an MRI
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance


Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • Concurrent epoetin alfa allowed
  • No concurrent anticancer biologic therapy


  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent anticancer cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • More than 4 weeks since prior hormonal or steroid therapy (other than replacement)
  • No concurrent anticancer hormonal therapy (except for replacement)
  • No concurrent dexamethasone or prednisone


  • More than 4 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy


  • More than 4 weeks since prior major surgery
  • No concurrent surgery for cancer


  • Recovered from prior therapy
  • More than 4 weeks since prior investigational agents
  • More then 28 days since prior alteration of antihypertensive medications
  • Concurrent bisphosphonates allowed
  • No other concurrent anticancer therapy
  • No concurrent antidepressants (e.g., amitriptyline, fluoxetine, or fluvoxamine)
  • No concurrent oral hypoglycemics (e.g., glipizide, glyburide, rosiglitazone, or tolbutamide)
  • No concurrent therapeutic anticoagulation (e.g., warfarin at therapeutic doses)

    • Low-dose anticoagulation for prophylaxis allowed
  • No concurrent cyclosporine
  • No concurrent grapefruit juice
  • No concurrent amiodarone, mibefradil, phenobarbital, or pioglitazone
  • No concurrent Hypericum perforatum (St. John's Wort)
  • No concurrent rifabutin or diethyldithiocarbamate
  • No concurrent gestodene, mifepristone, or modafinil
  • No concurrent herbal supplements, vitamins, or non-traditional compounds
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP